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Table 7B: Policy on Service Standards for External Fees

Healthy Environments and Consumer Safety Branch (HECS)


External Fee

Service Standard

Performance Result

Stakeholder Consultation

National Dosimetry Services Product, Services and Fee Structure  (NDS P, S&F)

Provide timely, responsive and reliable customer services to 95,000 workers in 13,000 groups:

Registration and inspections of incoming dosimeters within 48 hours

Exposures over regulatory limits reported within 24 hours

Dosimeters leave NDS premises 10-13 working days prior to exchange date

Message call backs (phone, e-mail) within 24 hours

Updated account information within 48 hours

Additional request dosimeters shipped within 24 hours
Exposure Reports for regular service sent out within 10 days of dosimeter receipt

Provided timely, responsive and reliable customer services to 95,000 workers in 13,000 groups.  The standards were met as follows:
99%    Registration & inspection of incoming dosimeters  within 48 hours
100%  Exposures over regulatory limits reported within 24 hours
97%    Dosimeters leave NDS premises 10-13 working days prior to exchange date
99%    Message call backs done within 24 hours
99%    Account information updated within 48 hours
99%    Additional request dosimeters shipped within 24 hours
90%    Exposure Reports sent out within 10 days of dosimeter receipt

NDS manages client contacts ( 55, 000 this year) on a daily basis through the Call Centre system.  This allows NDS to measure level of service satisfaction as well as insight into new requirements for products and services.  NDS documents and assess customer feedback (compliments and criticism) using a centralized electronic database directly connected to the Call Centre system.  Additional information on service is obtained during regular contact sessions with the client and, as required, through exit questionnaires.  This year, NDS will be engaging selected clients in service specific questionnaire.  On a basis of over 500,000 dosimeter readings annually, NDS satisfaction rate is more than  99.9%.

Deratting Services
Will be known as Ship Sanitation Cerficate Services as of June 17, 2007.

Health Canada provides 7-day service in designated ports and all requests are responded to within 48 hours.
See Note 1 below.

100% of requests received were responded to within 48 hours or less.

There were no changes to the service standards in 2006-2007.  The International Health Regulations (WHO) requires that the new Ship Sanitation Certificates be implemented by June 15, 2007.  The shipping industry was consulted by HC in the 2006-07 year.  Fees will not change until after December 15, 2007 when a new costing analysis will be completed.

Cruise Ship Inspection Program

Periodic inspections done a minimum of once a sailing season on ships in Canadian waters.
Final reports submitted within 10 working days.
Re-inspection on any ships with scores of less than 85%.

See Notes 2 and 3 below.
100%

There were no changes to the service standards in 2006-2007. Health Canada meets with stakeholders on an annual basis to review and discuss any proposed changes to the service standards.  The standards are consistent with the CDC/VSP (Vessel Sanitation Program) administrative guideline and criteria for inspections, and any changes would be synchronized to harmonize the process with the U.S.
The administrative guide was updated with minor changes in  2006-07, and will be implemented in April 2007.

Common Carrier Inspection (e.g. trains, ferries, airports/airlines, seaports)

See Note 3 below.

See Note 4 below.

Service standards are negotiated and included in MOUs/contracts; service standards/MOUs remain unchanged in 2006-07.  Stakeholders consulted at the annual HC-industry meeting.

Employee Assistance Services (EAS)
(Fee is charged through contractual or formally-based agreements between HC and other departments, agencies and federally-regulated organizations.)

As per formal agreement, varies depending on customer organization's requirements, needs and EAS capacity to meet these.

EAS is an Accredited service.  Voluntary satisfaction surveys, customer surveys and follow-ups with clients and customers are done on a regular basis.  Results are shared at year end with report to each customer, as per formal agreement.

Customer survey and meeting with customer at least once a year.  Formal agreement to renew contractual or MOU-type agreement done annually or every two years.  Utilization data given at least annually to each customer.

Medical Marihuana
Dried marihuana
($5.00 / gram)

Cannabis seeds
($20.00 / packet of 30 seeds)

Dried marihuana
Quality: Each lot is tested prior to distribution for potency and absence of specific contaminants.
Quantity: 14 working days (date of receipt of request to date of shipment)

Cannabis seeds
Quality: Each batch is tested for germination rate and mature plants morphological and chemical attributes.
Quantity: 5 working days  (date of receipt of request to date of shipment).

Dried marihuana
Requirements were met for all eight lots distributed to authorized persons (A.P.) (Quality control results posted on Health Canada website).  Return rate due to product non-satisfaction = 0.48% (33 pouches out of 6,864 shipped), compared to a 1.09% non-satisfaction rate last fiscal year (53 pouches out of 4,828 shipped.
Total number dried marihuana shipment orders sent to A.P. = 2,100, compared to 1,412 sent last fiscal year.
Cannabis seeds
Current cannabis seeds batch distributed for the period of April 1, 2006 through to March 31, 2007. Return rate due to product non-satisfaction = 1.7% (6 packets out of 348 packets shipped) (Please note that the return rate for seeds may not necessarily be due to non-satisfaction but because they decided not to grow or it was undeliverable).  Last fiscal year, there was a 0.89% return rate due to non-satisfaction (3 packets out of 336 shipped).
Total number seeds shipment orders sent to A.P. = 185, compared to 196 last fiscal year.

As a result of comments received from the first users of marihuana produced under contract for Health Canada, a "bud" only product with increased potency has been distributed by Health Canada since May 2004.  Additional changes to the physical attributes of dried marihuana resulting in a marihuana product with higher humidity and larger particle size were made September 2005, thus increasing the quality of the product.
Based on feedback received from clients, since August 2004, Health Canada has been offering three different pouch sizes to allow new A.P. to try a smaller size pouch product; therefore allowing clients the opportunity to pay for opened smaller size pouches in the advent the product does not meet their needs.
Processing time was calculated and based on historical data accumulated over a period of a year.


Note 1: In total, 675 Derat certificates were issued in 2006-2007.  See table below for details on service standards.


Day of the Week

Prior Notification Required

Weekday Service - Designated Ports

24 hours

Weekend Service - Designated Ports

48 hours

Regular Weekend Service - Designated Ports

For service on Saturday, notice must be received Thursday by 1300 hours local time.
For service on Sunday, notice must be received Friday by 1300 hours local time.

Holiday Weekend Service - Designated Ports

When Friday is the statutory holiday

  • for service on Friday, notice must be received Wednesday by 1300 hours local time;
  • for service on Saturday or Sunday, notice must be received Thursday by 1300 hours local time.

When Monday is the statutory holiday

  • for service on Saturday, notice must be received Thursday by 1300 hours local time;
  • for service on Sunday or Monday, notice must be received Friday by 1300 hours local time.

Prior Notice for Service - Non-designated Ports

72 hours prior notice is requested for service at non-designated ports.


NOTE: The fee for short notice service i.e. less than 24 hours for week days, less than 48 hours for weekends, at both designated and non-designated ports, will be the normal fee plus a 25% surcharge.

Note 2: Health Canada publishes scores obtained from the Cruise Ship Inspection Program at: http://www.hc-sc.gc.ca/hl-vs/travel-voyage/general/inspection/2006-cruise_ship_inspection-navires_croissieres_inspection_e.html

Note 3: In regards to service standards, Cruise Ship and Common Carrier Inspections are performed following procedures and protocols that have been published and distributed to clients.  Health Canada's protocols are consistent with programs in other countries.  Copies of the inspection protocols for these programs may be requested by e-mail at: phb_bsp@hc-sc.gc.ca.

Note 4: Service Standards for Conveyance Inspection Program


Conveyance Inspection Program

Service Standard

Performance Result

Passenger Train - On Board

Periodic inspection done on each passenger train line as determined by MOU between Health Canada and passenger train industry.
Final inspection report provided to industry within 10 working days.

100% of reports provided within 10 working days.

Passenger Train - Off  Board

Sanitation inspection done twice a year.
Final report provided to industry within 10 working days

100% of reports provided within 10 working days.

Flight Kitchen

Scheduled number of  announced audits per year is based on the number of meals prepared by the kitchen.
Final audit inspection report provided within 10 working days of inspection.

100% of reports provided within 10 working days.

Ferry - On Board Food

Unannounced inspections as per predetermined contractual obligations.
Final inspection report provided within 10 working days of inspection.

100% of reports provided within 10 working days.

Ferry - Potable Water

Unannounced inspections as per predetermined contractual obligations.
100% of reports provided within 10 working days.

100% of reports provided within 10 working days.


B.  Other Information
National Dosimetry Services
NDS billed for $ 5.2 M in 2006/2007, and collected $ 4.5 M in net vote/re-spendable cash.  A plan is being developed to integrate a new product, - the next generation dosimeter -  by 2008/9., as well as  modifications to address gaps in financial performance ( ie, cost of living), business capacity ( ie, competition), and client demands expectations for enhanced levels of other products and services.

As established pursuant to the Policy on Service Standards for External Fees:

  1. Service standards may not have received Parliamentary review; and
  2. Service standards may not respect all performance standard establishment requirements under the UFA (e.g. international comparison; independent complaint address)
  3. Performance results are not legally bound to section 5.1 of the UFA regarding fee reductions for underachieved performance.

Health Products and Foods Branch

NOTE: This table will not be included in the printed DPR


A. External Fee

Service Standard

Performance Result

Stakeholder Consultation

Authority to Sell Drugs Fees

120 calendar days to update the Drug Product Database following notification

96% within 120 calendar days

The Health Products and Foods Branch (HPFB) is actively engaging stakeholders in the development of a cost recovery framework, including relevant service standards.  An initial framework of cost recovery fees and service standards was developed in 2006-2007 and presented for consultation in April 2007.  Ongoing consultations are scheduled for 2007-2008, with fees and service standards targeted for implementation in 2008-2009. 

Certificates of Pharmaceutical Product (Drug Export) Fees

5 working days to issue certificate

95% certificates issued within 5 working days

Drug Establishment Licensing Fees

250 calendar days to issue / renew licence

90% licences issued/renewed within 300 calendar days

Drug Master File Fees

30 calendar days

100% within 30 calendar days

Drug Submission Evaluation Fees (Pharmaceuticals & Biologic Products)

NDS: Priority NAS = 180
NDS: NOC-C NAS = 200
NDS: NOC-C Clin / C&M = 200
NDS: NAS = 300
NDS: Clin/C&M=300
NDS: Clin only = 300
NDS: Comp / C&M = 300
NDS: Labelling only = 60
ANDS: C&M/Labelling = 180
ANDS: Comp/C&M = 180
SNDS: Priority Clin Only = 180
SNDS: Priority Clin / C&M = 180
SNDS: NOC-c Clin/ C&M = 200
SNDS: Clin/C&M = 300
SNDS: Clin only = 300
SNDS: Comp/C&M = 180
SNDS: C&M/ Labelling = 180
SNDS: Rx to OTC (switch) NNI = 180
SNDS: Labelling only = 60
SANDS: Comp / C&M = 180
SANDS: C&M / Labelling = 180
SANDS: Labelling only = 60
DIN with data = 210
DIN form only = 180

Average review time to first decision (calendar days)

Pharmaceutical Products
NDS: Priority NAS = 193
NDS: NOC-C NAS = 184
NDS: NOC-C Clin / C&M = 200
NDS: NAS = 251
NDS: Clin/C&M = 252
NDS: Clin only = 188
NDS: Comp / C&M = 230
ANDS: C&M/Labelling = 165
ANDS: Comp/C&M = 165
SNDS: Priority Clin Only = 156
SNDS: Priority Clin / C&M = 131
SNDS: NOC-c Clin/ C&M = 199
SNDS: Clin/C&M = 281
SNDS: Clin only = 250
SNDS: Comp/C&M = 224
SNDS: C&M/ Labelling = 176
SNDS: Rx to OTC (switch) NNI = 142
SNDS: Labelling only = 39
SANDS: Comp / C&M = 180
SANDS: C&M / Labelling = 168
SANDS: Labelling only = 58
DINA with data = 190
DINA form only = 149
DIND with data = 117
DIND form only = 138

Biologic Products
NDS: Priority NAS = 274
NDS: Priority Clin/C&M = 378
NDS: NOC-C Clin / C&M = 185
NDS: NAS = 560
NDS: Clin/C&M = 481
SNDS: Priority Clin Only = 175
SNDS: Clin/C&M = 381
SNDS: Clin only = 408
SNDS: Comp/C&M = 379
SNDS: C&M/ Labelling = 188
DINB with data = 130
DINB form only = 10

Medical Device Licence Application Fees

Time to first decision (calendar days)
Class II = 15 (process)
Class II amendment = 15 (process)
Class III = 75
Class III amendment = 75
Class IV = 90
Class IV amendment = 90

Time to first decision (calendar days)
13 to process
11 to process
52 to review
38 to review
62 to review
49 to review

Fees for Right to Sell a Licensed Medical Device

20 calendar days from deadline for receipt of annual notification to update the Medical Devices Active License Listing (MDALL) database

100% within 20 calendar days

Medical Device Establishment Licensing Fees

120 calendar days to issue / renew licence

90% licences issued/renewed within 120 calendar days

Veterinary Drug Evaluation Fees

Review time to first decision (calendar days)

NDS, ABNDS = 300
SNDS = 240
SABNDS = 240
Admin = 90
DIN = 120
NC = 90
IND/ESC = 60
Labels = 45
Emergency Drug Release = 2

Average review time to first decision (calendar days)
NDS = 671
SNDS = 539
SABNDS = 295
Admin = 134
DIN = 195
NC = 177
IND/ESC = 58
Labels = 28
90+% within 2 days

Fees and service standards related to veterinary drug product activities are under development, but no specific proposals have been presented to stakeholders.

B. Other Information:   


Pest Management Regulatory Agency

In order to reduce the volume of printed material, this table is not to be included in the printed DPR.


A. External Fee

Service Standard

Performance Result

Stakeholder Consultation

Fees to be paid for Pest Control Product Application Examination Service

Target is 90% of submissions in all categories to be processed within time shown.

Category A
Standard - 550 days User Request Minor Use Registration (URMUR) - 365 days Joint Reviews - variable Reduced risk - variable
Category B
Standard/priority - 365 days Reduced risk - variable
Category C
Standard - 180 or 225 days
Category D
Standard - variable
Category E
Standard - variable
*Includes deviations from Management of Submission Policy

Category A = 94%
Category B = 94%
Category C = 86%
Category D (Minor Use only) = 79%
Category E = 50%

Stakeholder consultation conducted annually when required.

Fees to be paid for the right or privilege to manufacture or sell a pest control product in Canada and for establishing a Maximum Residue Limit in relation to a pest control product.

 

100% of all fees for the right or privilege to manufacture or sell a pest control product in Canada have been invoiced by April 30th of the fiscal year

N/A

All stakeholders have been consulted on the proposed service standard for invoicing clients

B. Other Information


 Corporate Services Branch (CSB)


A.    External Fee

Service Standard

Performance Result

Stakeholder Consultation

Fees charged for the processing of access requests filed under the Access to Information Act (ATIA)

Response provided within 30 days following receipt of request; response time may be extended pursuant to section 9 of the ATIA. Notice of extension to be sent within 30 days of receipt of request.
ATIA

Of  2.017 requests, 1,643 (81.5%) were completed during 2006-2007.

The Department was able to respond within 30 days or less in 626 (38.1%) of completed cases. Response times for the remaining cases were 280 (17.0%) within
31 to 60 days, 400 (24.3%) within 61 to 120 days, and 337 (20.5%) in 121 or more days.

N/A

B. Other Information
N/A